Found (201) clinical trials

Prospective single-arm study of the AccuCinch Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair. Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.

The study will be performed as a randomized, double blind trial (in respect of the primary end point) with treatment of the stenotic lesion using uncoated PTA-catheters as control group. 114 patients will be included in the trial at about 5 study centers. Follow-up includes control angiography after 6 and ...

The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile

PERSIST-AVR is designed to collect data on sutureless valve (Perceval sutureless aortic heart valve), a new type of biological aortic valve, comparing data with standard biological aortic valve, considered the gold standard for aortic valve replacement. This prospective, randomized international multicenter study is planned to demonstrate, as primary endpoint, the ...

This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System. This study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in the SFA and in popliteal arteries, ranging in diameter ...

Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries Cohort 2: To evaluate this patient population for treatment of in-stent restenotic ...

The primary objective of the Chocolate Touch study is to demonstrate non-inferior safety and non-inferior effectiveness of the Chocolate Touch compared to the Lutonix drug coated balloon catheter. These data are intended to show safety and effectiveness of the Chocolate Touch sufficient to support regulatory approval to market this device ...

Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography ...

After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel ...